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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04768998
Other study ID # 01KX2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 4, 2020
Est. completion date September 2023

Study information

Verified date February 2021
Source Goethe University
Contact Jörg J Vehreschild, Prof.
Phone +49 221 478-88794
Email Janne.Vehreschild@kgu.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The intersectoral platform is part of the National Pandemic Cohort Network (NAPKON) and will be used to provide a comprehensive and harmonized collection of data and biomaterial for researchers from national consortia, pharmaceutical companies and for participation in international research collaborations for the purpose of studying COVID-19 disease and future pandemics.


Description:

The intersectoral platform is part of the National Pandemic Cohort Network (NAPKON), which, together and in interaction with other components of the National Research Network of University Medicine on COVID-19 (NUM), provides the essential basis for the successful understanding and thus combating pandemics using the example of coronavirus disease 2019 (COVID-19). NAPKON represents a sustainable, integrative and comprehensive concept that provides benefits for society as a whole in defending against and coping with pandemics, especially at the level of public health care, in hospital and patient management and from the individual patient's perspective. The intersectoral platform records data and biomaterial of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2)-infected patients through a network of university clinics, hospitals at all levels of care, general practitioners and specialist practices with appropriate study experience and infrastructure. The longitudinal phenotyping programme tracks patients for up to one year and collects detailed and harmonized clinical data as well as biomaterial. Follow-up data is enriched by patient-reported outcomes (PROM) and recruitment is intensified by focusing on hot-spot regions. Mobile study teams are used to reach, among others, long-term care and rehabilitation facilities, thus mapping all structural elements of the German care network. The primary aim of the intersectoral platform is to provide a comprehensive and harmonized collection of data and biomaterial for researchers from national consortia, pharmaceutical companies and for participation in international research collaborations for the purpose of studying COVID-19 disease and future pandemics.


Recruitment information / eligibility

Status Recruiting
Enrollment 6550
Est. completion date September 2023
Est. primary completion date March 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age =18 years 2. Compliance with the case definition (a-c): 1. Polymerase chain reaction (PCR) or rapid test diagnosis from nasopharynx, bronchoalveolar lavage, oropharynx, stool and/or blood 2. or a combination of: - negative molecular detection of SARS-CoV-2 AND - characteristic radiological findings AND - respiratory tract infection AND - absence of a more likely cause of disease, in particular other chronic lung diseases AND - Negative test for influenza 3. or (control group) a combination of: - negative molecular detection of SARS-CoV-2 AND - respiratory tract infection AND - absence of a more likely cause of disease, in particular other chronic lung diseases AND - attempt of pathogen identification from respiratory material with at least culture and influenza test 3. The baseline visit needs to be performed a maximum of 7 days (168h) after sampling and 4 days (96h) after the case definition is available. 4. Signed informed consent Exclusion Criteria: 1. Age <18 years 2. Paediatric patients will not be included at the beginning of the study (amendment in preparation).

Study Design


Related Conditions & MeSH terms

  • Coronavirus Infections
  • Severe Acute Respiratory Syndrome
  • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Intervention

Other:
Observational of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings
Observatory Cohorts focusing (I) on subjects after SARS-CoV-2 infection that are recruited from the general population (POP), and on subjects with acute SARS-CoV-2 infections recruited (II) in university hospital high-care settings or (III) general health care.

Locations

Country Name City State
Germany RWTH Aachen Aachen
Germany University Hospital Augsburg Augsburg
Germany Charité Berlin Berlin
Germany Klinikum Bielefeld Bielefeld
Germany University Hospital Ruhr-University Bochum Bochum
Germany University Hospital Bonn Bonn
Germany University Hospital Cologne Cologne
Germany University Hospital Carl Gustav Carus Dresden Dresden
Germany University Hospital Dusseldorf Dusseldorf
Germany University Hospital Erlangen Erlangen
Germany University Hospital Essen Essen
Germany Johann Wolfgang Goethe University Frankfurt am Main
Germany University Hospital Freiburg Freiburg
Germany University Hospital Göttingen Göttingen
Germany University Hospital Greifswald Greifswald
Germany University Hospital Halle Halle/Saale
Germany University Hospital Hamburg-Eppendorf Hamburg
Germany University Hospital MMH Hannover Hannover
Germany University Hospital Heidelberg Heidelberg
Germany University Hospital UKS Homburg Homburg
Germany University Hospital Jena Jena
Germany University Hospital UKSH Schleswig-Holstein Kiel
Germany University Hospital Leipzig Leipzig
Germany University Hospital UKSH Schleswig-Holstein Lübeck
Germany University Hospital Mannheim Mannheim
Germany University Hospital Giessen/Marburg Marburg
Germany University Hospital LMU Munich Munich
Germany University Hospital TUM Munich Munich
Germany University Hospital Münster Münster
Germany Klinikum Oldenburg Oldenburg
Germany University Hospital Regensburg Regensburg
Germany University Hospital Tübingen Tübingen
Germany University Hospital Ulm Ulm
Germany University Hospital Würzburg Würzburg

Sponsors (2)

Lead Sponsor Collaborator
Goethe University Nationwide Network of University Medicine (NUM) on Covid-19

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Longitudinal collection of data and biomaterial To provide a comprehensive and harmonised collection of data and biomaterial for researchers from national consortia, pharmaceutical companies and for participation in international research collaborations for the purpose of studying COVID-19 and future pandemics. day 1 of enrollment in the study, immediately before discharge, 3 and 12 months after diagnosis
Secondary Number of cases of SARS-CoV-2 infection Determine the number of cases of SARS-CoV-2 according to:
Severity of the disease
Deaths
Treatment status
Lengths of hospitalization
Duration of oxygen therapy
Underlying disease
12 months
Secondary Changes in concentration of inflammatory parameters. The changes of inflammatory parameters such as C-reactive protein (CRP) [mg/l], will be recorded and evaluated at all visits during the acute phase, if provided. Assessement at each study visit until discharge or death, assessed up to 12 months
Secondary Changes in concentration of cardiac parameters. The changes of Fibrinogen [µmol/l] will be recorded and evaluated at all visits during the acute phase, if provided. Assessement at each study visit until discharge or death, assessed up to 12 months
Secondary Changes in concentration of urine parameters. The changes in concentration of urine parameters such as Albumine ([mg/g Creatinin], will be recorded and evaluated, if provided. Assessment of the urine parameters will be performed at all visits during the acute phase until discharge or death, assessed up to 12 months
Secondary Changes in Patient-reported Quality of life recorded with the help of the European Quality of Life 5 Dimensions 5 Level Version (Eq5d5l) questionnaire. Health related quality of life after hospital discharge will be assessed with the questionnaire European Quality of Life 5 Dimensions 5 Level Version (Eq5d5l) Date of admission, immediately before discharge, 3, 6, 12 months after first diagnosis
Secondary Changes in body temperature. Assessment of the patient´s body temperature will be performed at all visits during the acute phase. Assessement at each study visit until discharge or death, assessed up to 12 months
Secondary Changes in blood pressure. Assessment of the patient´s blood pressure will be performed at all visits during the acute phase. Assessement at each study visit until discharge or death, assessed up to 12 months
Secondary Changes in heart rate. Assessment of the patient´s heart rate will be performed at all visits during the acute phase. Assessement at each study visit until discharge or death, assessed up to 12 months
Secondary Changes in breath frequency. Assessment of the patient´s breath frequency will be performed at all visits during the acute phase. Assessement at each study visit until discharge or death, assessed up to 12 months
Secondary Changes in peripheral oxygen saturation. Assessment of the patient´s peripheral oxygen saturation will be performed at all visits during the acute phase. Assessement at each study visit until discharge or death, assessed up to 12 months
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